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NCT Number: NCT04751812

Venous Cannulation Pain to Guide Choice of Anesthetic Method

The investigators have recently shown that pain associated with peripheral venous cannulation can be used to predict the risk of postoperative pain, where patients grading their pain associated with venous cannulation (VCP) above 2.0 VAS units had 3.4 times higher risk of moderate or severe postoperative pain after laparoscopic cholecystectomy and 1.7 times higher risk in a mixed group of patients and surgeries.

The aim of this study is to investigate whether pain sensitivity measurements using VCP can be used to choose anesthesia treatment protocol with the aim to lower acute postoperative pain in those with high risk. In patients with low risk we aim to lower the amount of opioids given.

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Key information

Conditions

Pain, Postoperative Anesthesia Opioid Free Laparoscopic Surgery Neurologic Manifestations Pain Pain Prediction Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Venous Cannulation Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Halland Hospital Halmstad

Halmstad, Halland County, 30582, Sweden

About this study

The investigators will perform a randomized controlled trial randomizing patients to different treatment protocols depending on their pain associated with venous cannulation. There will be two set of instructions for perioperative treatment, one for those grading pain associated with venous cannulation <2.0 (low-pain) and another for those grading VCP ≥2.0 (high-pain).

The low-pain group will be randomized to standard treatment or opioid-free anesthesia. The high-pain group will be randomized to standard treatment or extra in form of additives like esketamine and clonidine.

In the low-pain group the investigators aim for non-inferiority with the gain being avoiding opioids. In the high-pain group the investigators aim for lower post-operative pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with an American Society of Anesthesiologists (ASA) physical status I or II, undergoing elective laparoscopic surgery at Hallands´ hospital.

Exclusion criteria

  • Inability to understand information regarding the study. Refusal to give consent. Severe cardiovascular disease. AV-block II. Requirement of additional procedures during surgery, like conversion of laparoscopic to open surgery, incomplete registration of study measurements.

Treatment and study plan

High-pain multimodal anesthesia with opioids

Procedure

Paracetamol, Etoricoxib, Oxycodone, Ondansetron po. Betamethasone 4 mg iv.

Anesthesia:

As "standard" + bolus esketamine 0.25 mg/kg iv + Clonidine 1 µg/kg i.v.

Postoperative pain treatment:

At pain NRS ≥ 4 - 5 mg of oxycodone i.v. Paracetamol will be administered every 6 hours. If above is not sufficient bolus Clonidine 1 µg/kg i.v.

Other names: More extensive pain treatment

Low-pain opioid free

Procedure

Paracetamol, Etoricoxib, Ondansetron p.o. Betamethasone 4 mg iv.

Anesthesia:

Infusion Dexmedetomidin 0.2 mikrogram/kg/h iv started 5 min before induction Induction: Esketamin 0.1mg/kg + Propofol 1.5-2 mg/kg iv + rocuronium 0.5 mg/kg iv Start of surgery: Esketamin 0.1 mg/kg iv. Maintenance of anesthesia: Sevoflurane Dexmedetomidin inf 0.2 mikrogram/kg/h Esketamin inf 0.1-0.3mg/kg/h and 0.1 mg/kg adjusted after BP and HR 30 min before end of surgery Lidocaine 1 mg/kg iv

Postoperative pain treatment:

  • Dexmedetomidin (inf 01-0.2 µg/kg/h) 4 hours postoperative

If pain NRS ≧3 Esketamin 0.1mg/kg iv + Lidocain 0.5 mg/kg iv (max 4 mg/kg /4 h) If pain NRS ≧3 within 30 min after treatment above is given with Esketamin + Lidocain, 2.5 mg Oxycodone iv. is given and may be repeated.

Other names: Opioid free anesthesia

Standard of care

Procedure

Paracetamol, Etoricoxib, Oxycodone, Ondansetron p.o. Betamethasone 4 mg iv.

Anesthesia:

Target controlled infusion (TCI) with doses of propofol and remifentanil based on age, weight and height. Oxycodone 0.1 mg/kg 30 minutes before cessation of remifentanil.

Postoperative care:

At pain NRS ≥ 4 - 5 mg of oxycodone i.v. Paracetamol will be administered every 6 hours. If above is not sufficient bolus Clonidine 1 µg/kg i.v.

Primary outcomes

  1. Acute postoperative pain

    Time frame: Acute, within 1.5 hours after surgery

    Difference in mean APOP between groups (Opioid free vs Standard of care, Multimodal vs Standard of care). Reported as difference in NRS (numeric rating scale; 0-10 with 0 describing no pain and 10 the worst pain imaginable) with confidence interval (CI).

Secondary outcomes

  1. Proportion of patients with moderate-severe postoperative pain

    Time frame: Acute, 24 hours and 3 months after surgery

    Reported as difference in NRS (numeric rating scale; 0-10 with 0 describing no pain and 10 the worst pain imaginable) with confidence interval (CI).

  2. Association between pain catastrophizing scale and venous cannulation pain

    Time frame: Preoperative measurement

    Correlation between values on the pain catastrophizing scale and venous cannulation pain measured on a visual analog scale (0.0-10.0 with 0.0 describing no pain and 10.0 the worst pain imaginable)

  3. Association between pain catastrophizing and postoperative pain

    Time frame: Acute, within 24 hours after surgery

    Correlation between values on the pain catastrophizing scale and postoperative pain measured on a numeric rating scale (0-10 with 0 describing no pain and 10 the worst pain imaginable)

  4. Association between pain catastrophizing and postoperative pain

    Time frame: At 3 months after surgery

    Correlation between values on the pain catastrophizing scale and postoperative pain measured on a numeric rating scale (0-10 with 0 describing no pain and 10 the worst pain imaginable)

  5. Persistent postoperative pain

    Time frame: At three months after surgery

    Difference in occurence of persistent postoperative pain (assessed via a questionnaire as ocurring or not) comparing the pain sensitive group (VCP >2.0) and pain tolerant group (VCP<2.0).

  6. Difference in persistent pain between groups.

    Time frame: Three months after surgery.

    Difference in mean PPOP between groups (Opioid free vs Standard of care, Multimodal vs Standard of care). Reported as difference in NRS (numeric rating scale; 0-10 with 0 describing no pain and 10 the worst pain imaginable) with confidence interval (CI).

    Multimodal vs Standard of care). Reported as difference in NRS with confidence interval (CI).

  7. Venous cannulation pain for prediction of acute postoperative pain

    Time frame: Acute; within 24 hours

    Difference in mean APOP between pain-sensitive and pain-tolerant groups (SOC VCP≥2,0 vs SOC VCP≤1,9). Reported as difference in NRS (numeric rating scale; 0-10 with 0 describing no pain and 10 the worst pain imaginable) with confidence interval (CI).

  8. Venous cannulation pain for prediction of persistent postoperative pain

    Time frame: Three months after surgery

    Difference in ocurrence of PPOP between pain-sensitive and pain-tolerant groups (SOC VCP≥2,0 vs SOC VCP≤1,9). Reported as difference in NRS (numeric rating scale; 0-10 with 0 describing no pain and 10 the worst pain imaginable) with confidence interval (CI).

  9. Quality of recovery

    Time frame: Acute; within 24 hours

    Difference in Quality of recovery (QoR) after 24 hr between groups (OFA vs SOC, MAO vs SOC)? QoR assessed with the QoR-15 validated questionnaire answered by the patient 24 hours post surgery.

Other outcomes

  1. Proportion of patients with APOP depending on venous cannulation pain

    Time frame: Acute; within 24 hours

    Difference in proportion of patients experiencing moderate to severe APOP (NRS ≥ 4.0) between pain-sensitive and pain-tolerant groups (SOC VCP≥2,0 vs SOC VCP≤1,9)

Sponsors and collaborators

Lead sponsor

Region Halland

Other

Collaborators

  • Lund University

Registry information

Official study title

The Use of Venous Cannulation Pain for Evaluation of Pain Sensitivity in an Attempt to Guide Pain Therapy During and Following Anesthesia

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2021
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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